NCT03097523已完成不适用
Validation of a Cephalad Fluid Shift Countermeasure: Selection of Optimal Thigh Cuff Design Followed by Intracranial Pressure (ICP) Measurements During Extended Thigh Cuff Application
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Changes in intracranial pressure using cerebral and cochlear fluid pressure (CCFP) analyser and a disposable pressure transducer
研究概览
简要总结
This is a feasibility study to determine optimal thigh cuff design using a cephalad fluid shift protocol in patients who have an intraventricular catheter (such as Ommaya reservoir) placed for the delivery of central nervous system chemotherapy or for diagnosing potential elevation of ICP and monitoring its progression as part of standard medical care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18-89 years old
- •Willing and able to provide informed consent
- •Patients who have an intraventricular catheter placed for the delivery of central nervous system chemotherapy or for diagnosing potential elevation of ICP and monitoring its progression as part of standard medical care
- •For patients on active anti-cancer (intra-thecal or IV) therapy, must be at least 2 weeks since last treatment; oral therapy is permitted
排除标准
- •Less than 2 weeks since any prior surgery
- •ICP > 20 mmHg that cannot be clinically stabilized
- •Pregnant (Note: women of child-bearing potential must have a negative urine pregnancy test; women who are not of child-bearing potential are defined as: post-menopausal, age > 55 years with cessation of menses for 12 or more months; or less than 55 years with postmenopausal status confirmed by follicle-stimulating hormone in the post-menopausal range; or who have had a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy)
- •Existing cardiovascular disease, diabetes, syncope, ocular disease that, in the opinion of the investigator, may confound the study results
- •Uncontrolled neurological symptoms such as headache, nausea or vomiting that, in the opinion of the investigator, will limit the patient's ability to participate in the study
- •Injury, trauma, venous thromboembolism, peripheral arterial disease or any condition that, in the opinion of the investigator, will prevent the subject from tolerating the application of a thigh cuff; history of treated DVT is permitted
研究组 & 干预措施
Study Arm
Experimental
Patients with intraventricular catheter meeting eligibility criteria will undergo the following procedures:
- Blood pressure, heart rate, electrocardiogram and Intracranial Pressure (ICP) monitoring after standard of care procedures are completed
- Continuous ICP monitoring using a disposable pressure transducer (i.e., TruWaveTM)
- Sequential placement in an upright, seated, supine 0°, and supine 15° head down tilt (HDT) positions for approximately 15 minutes for stabilization, followed by: Non-invasive ICP, intra-ocular pressure (IOP) assessment, femoral vascular ultrasound, jugular vascular ultrasound, and assessment of adverse events
干预措施: Custom Thigh Cuff (Device)
结局指标
主要结局
Changes in intracranial pressure using cerebral and cochlear fluid pressure (CCFP) analyser and a disposable pressure transducer
时间窗: 20 minutes
Noninvasive and invasive ICP monitoring following standard of care procedures requiring access to ventricular catheter
次要结局
未报告次要终点
研究者
研究点 (2)
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